Postoperative Liver InjuryNCT07927101
Effects of a Preoperative Capsaicin-Containing Diet on Postoperative Liver Injury Repair: A Randomized Controlled Trial
A study testing Capsaicin-Containing Jelly in people with Postoperative Liver Injury and Liver Regeneration, run by Tongji Hospital.
Trial summary
The goal of this clinical trial is to learn whether a capsaicin-containing diet started before surgery can reduce liver injury and help the liver recover in adults aged 18 to 75 years who are scheduled for surgery to remove part of the liver because of a liver mass. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Liver Injury, Liver Regeneration
- What is being tested?
- Capsaicin-Containing Jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years, of any sex.
- A focal liver lesion scheduled for elective open or laparoscopic liver resection, such as hepatocellular carcinoma, colorectal liver metastases, or hepatic hemangioma.
- Child-Pugh class A or B with a score of 7 or less, and indocyanine green retention at 15 minutes (ICG-R15) of 20% or less.
- Planned intraoperative hepatic inflow occlusion.
- An anticipated future liver remnant of at least 30% in patients with a normal liver or at least 40% in patients with cirrhosis.
- Ability to tolerate an oral chili powder challenge, such as 0.5 g without gastrointestinal discomfort.
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- Willingness and ability to comply with the standardized study diet initiated 2 days before surgery, with a planned capsaicin dose of 7.5 mg/day in three divided doses with meals for participants assigned to the capsaicin group, and provision of written informed consent.
- No severe cardiac, pulmonary, or renal dysfunction, with an estimated glomerular filtration rate (eGFR) of at least 60 mL/min.
- No history of liver transplantation or other organ transplantation.
Who cannot join
- Pregnancy or breastfeeding.
- A history of or current malignancy other than the disease for which liver resection is planned, unless cured for at least 5 years without recurrence. Hepatocellular carcinoma scheduled for resection, and colorectal liver metastases together with their corresponding colorectal primary cancer, are not excluded under this criterion.
- Persistent preoperative elevation of transaminases or total bilirubin above twice the upper limit of normal that does not improve with treatment, or a white blood cell count below the lower limit of normal.
- A requirement for a combined radical oncologic procedure, such as pancreaticoduodenectomy or radical resection for hilar cholangiocarcinoma.
- Tumor thrombus in the main portal vein, the right or left portal vein branch, a hepatic vein, or the inferior vena cava.
- Severe cirrhosis with a Child-Pugh score of 8 or higher, or moderate to severe esophagogastric varices identified by endoscopy.
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- Active bleeding, a coagulation disorder with an international normalized ratio (INR) greater than 1.5 or a platelet count below 100 × 10^9/L, or another contraindication to surgery.
- Severe cardiac, pulmonary, or renal dysfunction, defined as New York Heart Association (NYHA) functional class III or IV, forced expiratory volume in 1 second (FEV1) below 50% of the predicted value, or eGFR below 60 mL/min.
- A history of or current active peptic ulcer disease, severe gastritis, gastroesophageal reflux disease (GERD), or a known allergy to chili powder or capsaicin.
- Severe infection, active tuberculosis, autoimmune hepatitis, or another acute or chronic systemic disease.
- Participation in another interventional clinical trial or use of an investigational drug affecting liver function within the preceding 3 months.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn whether a capsaicin-containing diet started before surgery can reduce liver injury and help the liver recover in adults aged 18 to 75 years who are scheduled for surgery to remove part of the liver because of a liver mass. Capsaicin is the substance that makes chili peppers spicy. The study will also assess the safety and tolerability of this diet.
The main questions it aims to answer are:
Read more
Does the capsaicin-containing diet help blood levels of alanine aminotransferase (ALT), a marker of liver injury, fall more quickly between the first and fifth days after surgery?
Does it improve other measures of liver recovery and reduce liver failure after surgery?
What side effects, including stomach or intestinal discomfort, occur during the study?
Researchers will compare a jelly containing chili powder with a similar-looking placebo jelly containing sweet pepper powder without capsaicin. Both groups will receive the same standard care before, during, and after surgery.
The study plans to enroll 110 participants. Participants will be assigned by chance to one of the two groups, with an equal chance of receiving either study diet. Participants and the researchers assessing their recovery will not know which diet they receive.
Participants will:
Take the assigned jelly three times daily with meals, starting 2 days before surgery and continuing through the evening of the first day after surgery, with a pause for surgery as directed by the study team. The capsaicin group will receive approximately 7.5 mg of capsaicin per day.
Avoid other spicy foods while taking the study diet.
Have blood tests before and after surgery to assess liver injury, liver function, and safety.
Report any discomfort or other health problems to the study team.
Complete follow-up assessments around 30 and 90 days after surgery to check recovery, complications, hospital readmissions, and survival.
- Conditions
- Postoperative Liver Injury, Liver Regeneration
- Being tested
- Capsaicin-Containing Jelly, Placebo Jelly
- Keywords
- Capsaicin, Dietary Intervention, Hepatectomy, Liver Regeneration, Postoperative Liver Recovery, Hepatic Ischemia-Reperfusion Injury, TRPV1, Calcitonin Gene-Related Peptide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin-Containing JellyOther
A food-based dietary intervention consisting of an oral jelly containing Thai chili powder. Each 15-mL serving contains 1.25 g of chili powder, providing approximately 2.5 mg of capsaicin. One serving is taken orally three times daily with meals, for a total of 3.75 g of chili powder and approximately 7.5 mg of capsaicin per day. Administration begins 2 days before surgery and continues through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period.
Placebo JellyOther
An oral placebo jelly containing sweet pepper powder without capsaicin, matched to the capsaicin-containing jelly in appearance and caloric content. One serving is taken orally three times daily with meals, beginning 2 days before surgery and continuing through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin-Containing Diet | Experimental | Not described Receives: Other: Capsaicin-Containing Jelly |
| Placebo Diet | Placebo comparator | Not described Receives: Other: Placebo Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
The postoperative ALT recovery rate is assessed using the decline in the natural logarithm of serum ALT between 24 and 120 hours after liver resection, expressed as a rate per 24 hours. Serum ALT is measured preoperatively and at 24 and 120 hours postoperatively. The preoperative measurement serves as the baseline reference.
Measured: From 24 to 120 hours after liver resection (postoperative days 1 to 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Liver InjuryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Guang Zhang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07927101
- Sponsor's protocol ID
- TJ-202512181
- Status last verified
- Nov 2026
- First submitted
- 4 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Preoperative Capsaicin-Containing Diet on Postoperative Liver Injury Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07927101
- Acronym / sponsor ID
- TJ-202512181
- Conditions
- Postoperative Liver Injury, Liver Regeneration
- Keywords
- Capsaicin, Dietary Intervention, Hepatectomy, Liver Regeneration, Postoperative Liver Recovery, Hepatic Ischemia-Reperfusion Injury, TRPV1, Calcitonin Gene-Related Peptide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether a capsaicin-containing diet started before surgery can reduce liver injury and help the liver recover in adults aged 18 to 75 years who are scheduled for surgery to remove part of the liver because of a liver mass. Capsaicin is the substance that makes chili peppers spicy. The study will also assess the safety and tolerability of this diet.
The main questions it aims to answer are:
Does the capsaicin-containing diet help blood levels of alanine aminotransferase (ALT), a marker of liver injury, fall more quickly between the first and fifth days after surgery?
Does it improve other measures of liver recovery and reduce liver failure after surgery?
What side effects, including stomach or intestinal discomfort, occur during the study?
Researchers will compare a jelly containing chili powder with a similar-looking placebo jelly containing sweet pepper powder without capsaicin. Both groups will receive the same standard care before, during, and after surgery.
The study plans to enroll 110 participants. Participants will be assigned by chance to one of the two groups, with an equal chance of receiving either study diet. Participants and the researchers assessing their recovery will not know which diet they receive.
Participants will:
Take the assigned jelly three times daily with meals, starting 2 days before surgery and continuing through the evening of the first day after surgery, with a pause for surgery as directed by the study team. The capsaicin group will receive approximately 7.5 mg of capsaicin per day.
Avoid other spicy foods while taking the study diet.
Have blood tests before and after surgery to assess liver injury, liver function, and safety.
Report any discomfort or other health problems to the study team.
Complete follow-up assessments around 30 and 90 days after surgery to check recovery, complications, hospital readmissions, and survival.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin-Containing Diet | Experimental | Other: Capsaicin-Containing Jelly |
| Placebo Diet | Placebo comparator | Other: Placebo Jelly |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years, of any sex.
- A focal liver lesion scheduled for elective open or laparoscopic liver resection, such as hepatocellular carcinoma, colorectal liver metastases, or hepatic hemangioma.
- Child-Pugh class A or B with a score of 7 or less, and indocyanine green retention at 15 minutes (ICG-R15) of 20% or less.
- Planned intraoperative hepatic inflow occlusion.
- An anticipated future liver remnant of at least 30% in patients with a normal liver or at least 40% in patients with cirrhosis.
Key exclusion criteria (11 listed)
- Pregnancy or breastfeeding.
- A history of or current malignancy other than the disease for which liver resection is planned, unless cured for at least 5 years without recurrence. Hepatocellular carcinoma scheduled for resection, and colorectal liver metastases together with their corresponding colorectal primary cancer, are not excluded under this criterion.
- Persistent preoperative elevation of transaminases or total bilirubin above twice the upper limit of normal that does not improve with treatment, or a white blood cell count below the lower limit of normal.
- A requirement for a combined radical oncologic procedure, such as pancreaticoduodenectomy or radical resection for hilar cholangiocarcinoma.
- Tumor thrombus in the main portal vein, the right or left portal vein branch, a hepatic vein, or the inferior vena cava.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin-Containing JellyA food-based dietary intervention consisting of an oral jelly containing Thai chili powder. Each 15-mL serving contains 1.25 g of chili powder, providing approximately 2.5 mg of capsaicin. One serving is taken orally three times daily with meals, for a total of 3.75 g of chili powder and approximately 7.5 mg of capsaicin per day. Administration begins 2 days before surgery and continues through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. | Other | Capsaicin-Containing Diet |
| Placebo JellyAn oral placebo jelly containing sweet pepper powder without capsaicin, matched to the capsaicin-containing jelly in appearance and caloric content. One serving is taken orally three times daily with meals, beginning 2 days before surgery and continuing through the evening of postoperative day 1, with perioperative interruption for surgery. Participants avoid other spicy foods during the intervention period. | Other | Placebo Diet |
Primary outcome
Postoperative Alanine Aminotransferase (ALT) Recovery Rate
Time frame: From 24 to 120 hours after liver resection (postoperative days 1 to 5).
The postoperative ALT recovery rate is assessed using the decline in the natural logarithm of serum ALT between 24 and 120 hours after liver resection, expressed as a rate per 24 hours. Serum ALT is measured preoperatively and at 24 and 120 hours postoperatively. The preoperative measurement serves as the baseline reference.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Capsaicin-Containing Jelly in people with Postoperative Liver Injury and Liver Regeneration, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Zhan (18163017789, zhanxinyu990618@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Alanine Aminotransferase (ALT) Recovery Rate (time frame: From 24 to 120 hours after liver resection (postoperative days 1 to 5).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.